BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA STEMMED TIBIAL CEMENTED

    MDR report key: 7886547 · Received September 18, 2018

    Report

    Report Number
    0001822565-2018-05060
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 23, 2018
    Report Date
    July 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 3007963827-2019-00212.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 3007963827-2019-00212.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: PERSONA PS STANDARD FEMORAL COMPONENT CAT#: 42500606401, LOT#: 63791675; ALL-POLY PATELLA CEMENTED 32 MM DIAMETER CAT#: 42-5402-000-32, LOT#: 63843853; ARTICULAR SURFACE FIXED BEARING PS CAT#: 42-5124-007-12, LOT#: 63314881. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 05059, 0001822565 - 2018 - 05060. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PROGRESSIVE LOOSENING AND CLICKING NOISE FIVE MONTHS AFTER INITIAL KNEE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724979 PERSONA STEMMED TIBIAL CEMENTED PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 63443525

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other